Prosthetic mitral valve, and methods and devices for deploying the prosthetic mitral valve

ABSTRACT

According to an aspect of some embodiments of the invention, there is provided a method of deploying an expandable prosthetic mitral valve in a subject, the method comprising: deploying a first component of the prosthetic mitral valve in a left atrium; deploying a second component of the prosthetic mitral valve in a left ventricle; and approximating the first and the second components so that leaflets of a native mitral valve are trapped between the first and the second components.

RELATED APPLICATION

This application claims the benefit of priority under 35 USC 119(e) ofU.S. Provisional Patent Application No. 61/488,180 filed May 20, 2011,the contents of which are incorporated herein by reference in theirentirety.

FIELD AND BACKGROUND OF THE INVENTION

The present invention relates to the field of cardiac surgery, and moreparticularly to the field of prosthetic heart valves, especiallyprosthetic mitral valves.

The human heart 10, depicted in cross-sectional long axis view in FIG.1A (during diastole) and 1B (during systole), is a muscular organ thatpumps deoxygenated blood through the lungs to oxygenate the blood andpumps oxygenated blood to the rest of the body by rhythmic contractionsof four chambers.

After having circulated in the body, deoxygenated blood from the bodyenters right atrium 12 through vena cava 14. Right atrium 12 contracts,pumping the blood through a tricuspid valve 16 into right ventricle 18,FIG. 1A. Right ventricle 18 contracts, pumping the blood through apulmonary semi-lunar valve 20 into the pulmonary artery 22 which splitsto two branches, one for each lung, FIG. 1B. The blood is oxygenatedwhile passing through the lungs and reenters the heart to the leftatrium 24. Left atrium 24 contracts, pumping the oxygenated bloodthrough the mitral valve 26 into the left ventricle 28, FIG. 1A. Leftventricle 28 contracts, pumping the oxygenated blood through the aorticvalve 30 into the aorta 32 to be distributed to the rest of the body,FIG. 1B.

In mitral valve 26, an approximately circular mitral annulus 34 definesa mitral valve orifice 36. Attached to the periphery of mitral annulus34 is an anterior leaflet 38 and a smaller posterior leaflet 40,leaflets 38 and 40 connected to papillary muscles 44 at the bottom ofleft ventricle 28 by chordae 46. The typical area of the mitral lumen ina healthy adult is between 4 and 6 cm² while the typical total surfacearea of leaflets 38 and 40 is significantly larger, approximately 12cm².

During diastole depicted in FIG. 1A, left atrium 24 contracts to pumpblood into left ventricle 28 through orifice 36 of mitral valve 26. Theblood flows through orifice 36, pushing leaflets 38 and 40 into leftventricle 28 with little resistance. The leaflets of aortic valve 30 arekept closed by blood pressure in aorta 32.

During systole, depicted in FIG. 1B, left ventricle 28 contracts to pumpblood into aorta 32 through aortic valve 30 which leaflets are pushedopen by the blood flow with relatively little resistance. Mitral annulus34 contracts, pushing leaflets 38 and 40 inwards and reducing the areaof mitral valve orifice 36 by about 20% to 30%. Papillary muscles 44contract, maintaining the tension of chordae 46 and pulling the edges ofleaflets 38 and 40, preventing prolapse of leaflets 38 and 40 into leftatrium 24. Leaflets 38 and 40 curve into left ventricle 28 and coapt toaccommodate the excess leaflet surface area, producing a coaptationsurface 42 that constitutes a seal. The typical length of coaptationsurface 42 in a healthy heart 10 of an adult is approximately 7-8 mm.The pressure of blood in left ventricle 28 pushes against theventricular surfaces of leaflets 38 and 40, tightly pressing leaflets 38and 40 together at coaptation surface 42 so that a tight leak-proof sealis formed.

An effective seal of mitral valve 26 during ventricular systole isdependent on a sufficient degree of coaptation, in terms of length, areaand continuity of coaptation surface 42. If coaptation surface 42 isinsufficient or non-existent, there is mitral valve insufficiency, thatis, regurgitation of blood from left ventricle 28 into left atrium 24during ventricular systole. A lack of sufficient coaptation may becaused by any number of physical anomalies that allow leaflet prolapse(e.g., elongated or ruptured chordae 46, weak papillary muscles 44) orprevent coaptation (e.g., short chordae 46, small leaflets 38 and 40).There are also pathologies that lead to a mitral valve insufficiencyincluding collagen vascular disease, ischemic mitral regurgitation(resulting, e.g., from myocardial infarction, chronic heart failure, orfailed/unsuccessful surgical or catheter revascularization), myxomatousdegeneration of leaflets 38 and 40 and rheumatic heart disease. Mitralvalve insufficiency leads to many complications including arrhythmia,atrial fibrillation, cardiac palpitations, chest pain, congestive heartfailure, fainting, fatigue, low cardiac output, orthopnea, paroxysmalnocturnal dyspnea, pulmonary edema, shortness of breath, and suddendeath.

Apart from humans, mammals that suffer from mitral valve insufficiencyinclude horses, cats, dogs, cows, sheep and pigs.

It is known to use open-heart surgical methods to treat mitralinsufficiency, for example by modifying the subvalvular apparatus (e.g.,lengthening or shortening chordae 46) to improve leaflet coaptation,implanting an annuloplasty ring to force mitral valve annulus 34 into anormal shape.

Aortic valves are known to suffer from aortic insufficiency or aorticstenosis. It is known to deploy a prosthetic aortic valve usingminimally invasive surgery to replace a malfunctioning native aorticvalve. Typically, an expandable frame (e.g., a stent or a ring)supporting artificial aortic leaflets is positioned inside the orificeof an aortic valve, typically endovascularly with a catheter passingthrough the aorta, but also transapically through a hole near the apexof the heart, passing into left ventricle 28. The frame is expandedacross the aortic annulus folding and overlying the native aortic valveleaflets, maintaining the prosthetic aortic valve in place by exertionof an axial force and by adopting an “hourglass” shape that distributesaxial forces on the native aortic valve annulus and the surroundingtissue. Commercially available prosthetic aortic valves include theLotus™ by Sadra Medical (Campbell, Calif., USA) and the CoreValve™ byMedtronic (Minneapolis, Minn., USA).

It has been suggested to deploy a prosthetic mitral valve, analogous toa prosthetic aortic valve. A challenge to implementing such suggestionsis retention of the prosthesis in place during ventricular systole.Unlike the aortic valve annulus that constitutes a stable anchoringfeature, especially when calcified, the mitral valve annulus is not asufficiently stable anchoring feature (less than half of the mitralvalve annulus is of fibrotic tissue) and is dynamic (changing size andshape as the heart beats). Further, unlike the aortic valve that is openduring ventricular systole, the mitral valve must withstand the highpressures in the left ventricle caused by contraction of the leftventricle during ventricular systole, pressures that tend to force amitral valve prosthesis deployed across a mitral valve annulus into theleft atrium.

Additional background art includes US Application No. 2011/0137397 byChau et al., which discloses “Embodiments of prosthetic valves forimplantation within a native mitral valve are provided. A preferredembodiment of a prosthetic valve includes a radially compressible mainbody and a one-way valve portion. The prosthetic valve further comprisesat least one ventricular anchor coupled to the main body and disposedoutside of the main body. A space is provided between an outer surfaceof the main body and the ventricular anchor for receiving a nativemitral valve leaflet.”

SUMMARY OF THE INVENTION

An aspect of some embodiments of the invention relates to prostheticheart valve. Optionally, to prosthetic mitral valves. Some embodimentsof the invention relate to methods and devices suitable for deployingprosthetic heart valves. Optionally, prosthetic mitral valves.

According to an aspect of some embodiments of the invention, there isprovided a method of deploying an expandable prosthetic mitral valve ina subject, the method comprising:

deploying a first component of the prosthetic mitral valve in a leftatrium;

deploying a second component of the prosthetic mitral valve in a leftventricle; and

approximating the first and the second components so that leaflets of anative mitral valve are trapped between the first and the secondcomponents.

In an exemplary embodiment of the invention, approximating comprisesapproximating by pulling a wire connecting the first and the secondelements.

In an exemplary embodiment of the invention, the method furthercomprises joining said first and second elements to maintain anapproximated position.

In an exemplary embodiment of the invention, approximating comprisestightly trapping the native mitral valve leaflets.

In an exemplary embodiment of the invention, the method furthercomprises piercing said leaflets by at least one of the first or thesecond components.

In an exemplary embodiment of the invention, the method furthercomprises piercing tissues surrounding said leaflets by at least one ofsaid first or said second components.

According to an aspect of some embodiments of the invention, there isprovided a prosthetic mitral valve suitable for deployment in amammalian heart, comprising:

a) an annulus part defining a prosthetic mitral valve lumen and having aproximal portion, the annulus part having a deployed configurationconfigured for deployment inside a left atrium of a heart wherein theproximal portion passes into the mitral valve annulus of the heart; and

b) a ventricle part, configured for deployment in a left ventricle of aheart having a deployed configuration configured for at least partiallyencircling the proximal portion of the annulus part.

According to an aspect of some embodiments of the invention, there isalso provided a deployment device for transapically deploying aprosthetic mitral valve contained therein, comprising:

a) a substantially tubular delivery housing including a delivery lumenhaving an opening at a distal end thereof, the delivery housingconfigured for transapical entry into a mammalian heart, distal endfirst;

b) inside the delivery lumen, an annulus part of a prosthetic mitralvalve defining a prosthetic mitral valve lumen and having a proximalportion, in a compact delivery configuration, the annulus part outwardlyradially expandable subsequent to release from the delivery housing to adeployed configuration configured for deployment inside a left atrium ofa heart in which deployed, wherein the proximal portion passes into themitral valve annulus of the heart;

c) inside the delivery lumen, proximally from the annulus part, aventricle part of the prosthetic mitral valve physically separate fromthe annulus part, in a compact delivery configuration, the ventriclepart outwardly radially expandable subsequent to release from thedelivery housing to a deployed configuration configured for deploymentin a left ventricle of a heart at least partially encircling theproximal portion of the annulus part;

d) an annulus-part release component allowing release of the annuluspart through the distal end of the delivery housing;

e) a ventricle-part release component allowing release of the ventriclepart through the distal end of the delivery housing; and

f) a joining component functionally associated with the annulus part andthe ventricle part, the joining component configured to bring theannulus part and the ventricle part together when the annulus part is inthe deployed configuration subsequent to release from the deliveryhousing, allowing deployment of the prosthetic mitral valve in a heart.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which the invention pertains. In case of conflict, thespecification, including definitions, will control.

As used herein, the terms “comprising”, “including”, “having” andgrammatical variants thereof are to be taken as specifying the statedfeatures, integers, steps or components but do not preclude the additionof one or more additional features, integers, steps, components orgroups thereof. These terms encompass the terms “consisting of” and“consisting essentially of”.

As used herein, the indefinite articles “a” and “an” mean “at least one”or “one or more” unless the context clearly dictates otherwise.

BRIEF DESCRIPTION OF THE FIGURES

Some embodiments of the invention are herein described with reference tothe accompanying figures. The description, together with the figures,makes apparent to a person having ordinary skill in the art how someembodiments of the invention may be practiced. The figures are for thepurpose of illustrative discussion and no attempt is made to showstructural details of an embodiment in more detail than is necessary fora fundamental understanding of the invention. For the sake of clarity,some objects depicted in the figures are not to scale. In the Figures:

FIGS. 1A and 1B schematically depict a normal adult human heart incross-sectional long axis view during atrial systole (FIG. 1A) andduring ventricular systole (FIG. 1B), to help understand someembodiments of the invention;

FIG. 2A depicts the annulus part and the ventricle part of an embodimentof a prosthetic mitral valve as described herein, in a compact deliveryconfiguration, in accordance with an exemplary embodiment of theinvention;

FIG. 2B depicts the annulus part and the ventricle part of theprosthetic mitral valve of FIG. 2A, in a deployed configuration, inaccordance with an exemplary embodiment of the invention;

FIG. 3 schematically depicts an embodiment of a deployment device usefulfor deploying a prosthetic mitral valve of FIGS. 2A and 2B in side crosssection, in accordance with an exemplary embodiment of the invention;

FIGS. 4A-4H depict the deployment of a prosthetic mitral valve using thedeployment device of FIG. 3, in accordance with an exemplary embodimentof the invention;

FIGS. 5A-5G depict the deployment of an additional embodiment of aprosthetic mitral valve, in accordance with some embodiments of theinvention;

FIG. 6 is a flowchart of a method of deploying the prosthetic mitralvalve, in accordance with an exemplary embodiment of the invention; and

FIG. 7 is flowchart of a method of treating a patient by mitral valvereplacement, in accordance with an exemplary embodiment of theinvention.

DESCRIPTION OF SOME EMBODIMENTS OF THE INVENTION

An aspect of some embodiments of the invention relates to prostheticheart valves. Optionally, to prosthetic mitral valves. Some embodimentsof the invention relate to methods and devices suitable for deployingprosthetic heart valves. Optionally, prosthetic mitral valves.

An aspect of some embodiments of the invention relates to a method ofdeploying a prosthetic mitral valve comprises; deploying a firstprosthetic mitral valve portion against the left atrial surface of themitral valve leaflets, deploying a second prosthetic mitral valveportion inside a left ventricle, and approximating the first and secondportions so that the mitral valve leaflets are trapped between the firstand second portions. Optionally, at least one wire connected the firstand second portions is used to guide the second portion towards thefirst portion. Alternatively, the wire is used to guide the firstportion towards the second portion. Alternatively, the wire is used toclose the distance between the first and second portions.

In an exemplary embodiment of the invention, anchoring is performed onlyto the leaflets, for example, the annular part and the ventricle partare placed on opposite sides of the leaflets and apply force to holdtightly to the leaflets. Alternatively, at least some support isprovided by the surrounding tissues, for example, the annulus partextends outwards against the fibrous ring and/or walls of the leftatrium. Potentially, the extending outwards of the annulus part preventsor reduces migration of the valve into the left ventricle.

In an exemplary embodiment of the invention, top and bottom portions arejoined to one another. Optionally, the joining is performed by elementsthat bend and/or clasps.

In an exemplary embodiment of the invention, the first and secondportion are joined and/or approximated so that the leaflets are clampedhard between the first and second portions. Potentially, the leafletsare clamped hard enough so that migration of the valve into the leftatrium (e.g., during systole) is prevented and/or migration into theleft ventricle (e.g., during diastole) is prevented. Optionally, theclamping is not hard enough to reduce blood flow to the leaflets tocause necrosis.

Optionally, a tether (e.g., as described below) is used to prevent orreduce migration of the valve.

In an exemplary embodiment of the invention, the pressure appliedbetween the first and second portions to the leaflets is maintained bytension in the wire connecting the first and second portions.Alternatively or additionally, the force is maintained by the attachmentelements connecting the first and second portions.

In an exemplary embodiment of the invention, the approximating does notneed to be exact, as some tolerance is allowed. Optionally, the secondportion is larger than the first portion, so that the second portionsurrounds the leaflets and/or the first portion.

The principles, uses and implementations of the teachings of theinvention may be better understood with reference to the accompanyingdescription and figures. Upon perusal of the description and figurespresent herein, one skilled in the art is able to implement theteachings of the invention without undue effort or experimentation. Inthe figures, like reference numerals refer to like parts throughout.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not necessarily limited in itsapplication to the details of construction and the arrangement of thecomponents and/or methods set forth herein. The invention is capable ofother embodiments or of being practiced or carried out in various ways.The phraseology and terminology employed herein are for descriptivepurpose and should not be regarded as limiting.

A potential advantage of some embodiments of the invention, is retainingthe deployed prosthetic mitral valve, especially during systole, againstthe generated high pressures in the left ventricle caused by contractionof the left ventricle, without forcing the prosthetic mitral valve intothe left atrium.

In an exemplary embodiment of the invention a prosthetic mitral valvecomprises two parts, an annulus part (e.g., for deployment in the leftatrium) and a ventricle part (e.g., for deployment in the leftventricle).

In an exemplary embodiment of the invention, when deployed, the annuluspart is deployed inside a left atrium across the mitral valve annulus(e.g., within the annulus). Optionally, the annulus part is deployedagainst the atrial aspect of the leaflets. Optionally or additionally,the annulus part is deployed within the native annulus against theleaflets so that the leaflets all or mostly lie inside the leftventricle (e.g., similar leaflet state as during diastole).

In an exemplary embodiment of the invention, the deployment occurs byretracting the expanded annulus part into the native mitral valveannulus. Alternatively, the annulus part is expanded within the nativeannulus.

In an exemplary embodiment of the invention, a proximal portion of theannulus part is sized and/or positioned so that the annulus part passesinto (and in some embodiments through) the mitral valve annulus.Optionally, the proximal portion is sized and/or positioned to extend toabout the edge of the native leaflets. Alternatively, the proximalportion is sized and/or positioned to extend past the edge of the nativeleaflets into the left ventricle.

In an exemplary embodiment of the invention, the ventricle part of theprosthetic mitral valve is deployed inside the left ventricle.Optionally, the ventricle part is displaced towards the mitral valveannulus (e.g., by pulling on the wire connecting the parts) so that theventricle part at least partially encircles the proximal portion of theannulus part. For example about 360 degrees along the circumference, orabout 345 degrees, or about 330 degrees, or about 315 degrees, or about300 degrees, or about 270 degrees, or other smaller or intermediatedimensions. Potentially, the use of the partially encircling ventriclepart does not require cutting the chords, as the partial circumferenceventricle part can be positioned even in the presence of the chords.Optionally, the ventricle part is fixed to the proximal portion of theannulus, for example, using anchoring elements, for example, bendingelements.

In some embodiments, the ventricle part of the prosthetic mitral valvehas a diameter about the same or larger than that of the native mitralvalve orifice. For example, the diameter is about 1 mm larger, or about3 mm, or about 5 mm, or about 7 mm, or about 10 mm, or other smaller,intermediate or larger diameters larger. Potentially, the largerdiameter allows easier positioning of the ventricle part around theleaflets and/or annulus part.

In an exemplary embodiment, the ventricle part of the prosthetic mitralvalve at least partially encircles the native mitral valve leaflets aswell as the proximal portion of the annulus part of the prostheticmitral valve, thereby trapping the leaflets between the ventricle andthe annulus parts. Optionally, both mitral leaflets are encircled.Alternatively, one leaflet is fully encircled and one leaflet is atleast partially encircled. Alternatively, one leaflet is at leastpartially encircled and one leaflet is not. Alternatively, none of themitral leaflets are encircled, but the portion of the annulus part(e.g., proximal portion) extending into the left ventricle is at leastpartially encircled or fixed thereto.

Thereby the ventricle part of the prosthetic mitral valve actssubstantially as a “locking ring”. Potentially, movement of theprosthetic mitral valve into the left atrium is prevented orsignificantly reduced, even during systole.

Exemplary Method of Treatment

FIG. 7 is a flowchart of a method of treating a patient in accordancewith an exemplary embodiment of the invention. It should be noted thatthe figure is not necessarily limited to the method described below, forexample, as some steps are optional and different devices can be used.

Optionally, at 702, a patient is selected for minimally invasive orpercutaneous mitral valve replacement, in accordance with an exemplaryembodiment of the invention. The patient is selected, for example, bythe treating physician. Some not necessarily limiting examples ofpatient indications include; non-surgical candidates, mitral valveprolapse, mitral valve stenosis,

In some embodiments, the heart is not stopped from beating during theprocedure, even as the prosthetic valve is deployed. Potentially,patients can be treated that would otherwise be refused surgery.Alternatively, the beating of the heart is stopped for at least part ofthe duration of the procedure.

Optionally, at 704, a suitable valve prosthesis adapted for anchoring tothe leaflets is selected, in accordance with an exemplary embodiment ofthe invention. Further details about the valve are provided, forexample, in the section “Exemplary Prosthetic Mitral Valve”.

Optionally, at 706, the prosthetic valve is inserted into the body, inaccordance with an exemplary embodiment of the invention. Optionally, apercutaneous approach is used. Optionally, one catheter is inserted intothe body to deliver the single component or dual component valve.Alternatively, two catheters are inserted, each catheter delivering onepiece of the two piece valve.

Some not necessarily limiting approaches include; femoral vein/jugularvein→right atrium→transseptal (e.g., punctured using a suitable needleor radiofrequency ablation device)→left atrium (→optional leftventricle); femoral artery→aorta→left ventricle (→optional left atrium).

Alternatively or additionally, a minimally invasive approach is used,for example, trans-apical. Alternatively or additionally, the open heartsurgery approach is used.

Optionally, the patient is placed under general anesthesia.Alternatively, conscious sedation is used. Alternatively oradditionally, local anesthesia is used.

In the case of the trans-apical approach, access to the left ventricularapex of the heart is gained, for example, through a left anterolateralmini-thoractomoy in the fifth intercostal space with horizontal openingof the pericardium and optionally placement of stay sutures forexposure. Optionally, a retractor is placed, exposing the heart apex.Optionally or additionally, two rows of 3-0 polpropylene pledgeted feltpurse string sutures are placed around the left ventricular apexcreating a 3-4 cm diameter area exposed for access. Optionally oradditionally, a 4000 Units of heparin bolus is administeredintravenously.

Optionally, at 708, the mitral valve leaflets are identified.Optionally, a TEE (trans-esophageal echo) probe is positioned to observethe left ventricular long axis of the heart throughout the operation.Optionally or additionally, the TEE is used to visualize the chords.

Other not necessarily limiting imaging modalities can be used toidentify the leaflets, for example, fluoroscopy.

At 710, the first component of the valve is deployed, in accordance withan exemplary embodiment of the invention. For example, deployment occursas described with reference to FIG. 8. Optionally, the first componentis deployed in the left atrium.

Optionally, at 712, the second component of the valve is deployed, inaccordance with an exemplary embodiment of the invention. For example,deployment occurs as described with reference to FIG. 8. Optionally, thesecond component is deployed in the left ventricle.

Optionally, at 716, the first and second components are approximated.Optionally or additionally, the first and second components are joinedtogether. For example, as described with reference to FIG. 8.

Optionally, at 714, the deployed prosthetic valve is evaluated.Optionally, the location of the valve is evaluated, for example, usingone or more imaging modalities such as ultrasound. Optionally oradditionally, the function of the valve is evaluated, for example, usingone or more imaging modalities to visualize the blood flow such asDoppler ultrasound.

Exemplary Prosthetic Mitral Valve

Thus, according to an aspect of some embodiments of the invention thereis provided a prosthetic mitral valve suitable for deployment in amammalian heart, comprising:

a) an annulus part, defining a prosthetic mitral valve lumen and havinga proximal portion, the annulus part having a deployed configurationconfigured for deployment inside a left atrium of a heart in whichdeployed wherein the proximal portion passes into (and in someembodiments, through) the mitral valve annulus; and

b) a ventricle part, configured for deployment in a left ventricle of aheart, the ventricle part having a deployed configuration configured forat least partially encircling the proximal portion of the annulus part.

In an exemplary embodiment of the invention, the annulus part and theventricle part are physically separate components.

In an exemplary embodiment, the ventricle part is sized and/or shaped,in the deployed configuration, to at least partially encircle the nativemitral valve leaflets of the heart in which deployed. In someembodiments the native mitral valve leaflets serve as a seal to reduceor prevent blood flow from regurgitating from the left ventricle to theleft atrium during systole. Potentially, the bulk and complexity of theprosthetic cardiac valve is reduced, for example, by not requiringadditional material to the annulus part to seal the valve againstregurgitation of blood.

In an exemplary embodiment, in the deployed configuration the annuluspart of the prosthetic mitral valve has a funnel shape, for example,having a narrower (axial dimension) proximal portion and a wider (axialdimension) distal portion. Alternatively, a cylinder shape is used.Optionally, when deployed in a heart, the wider distal portion restsagainst the inner walls of the left atrium in proximity of the nativemitral valve annulus. Alternatively, the wider distal portion does notrest against the left atrium walls, and/or the fibrous ring, but restsonly against the leaflets. For example, the distal portion is short ordoes not extend to the walls. Potentially the prosthetic mitral valve isprevented by the contact with the atrial walls from moving into the leftventricle, for example, during diastole.

In some embodiments, when deployed in a heart, the proximal portion ofthe annulus passes into the mitral valve annulus, and in someembodiments into the left ventricle, and in some embodiments even pastthe edges of the native mitral valve leaflets.

In an exemplary embodiment, in the deployed configuration the ventriclepart of the prosthetic mitral valve is ring-shaped (a partial or acomplete ring). The inner diameter of the ventricle part is sufficientto at least partially encircle the proximal portion of the annulus part,and in some embodiments, at least one of the native mitral valveleaflets of the heart are trapped by the encircling. Optionally, theventricle part has a relatively small axial dimensions in the deployedconfiguration so as to have an unobtrusive low profile when deployedinside a left ventricle, potentially not substantially interfering withleft ventricle functioning, for example by not partially occluding orcausing turbulence in the vicinity of the aortic valve.

Valve Mechanism

In an exemplary embodiment, the annulus part of the prosthetic mitralvalve includes a valve mechanism functionally associated with theprosthetic mitral valve lumen, for example, the valve is attached to theannulus part using one or more not necessarily limiting methodsincluding; dip molded thereon, glue, sutures, crimped. Alternatively,the valve mechanism is attached to the ventricle part. Alternatively,the valve mechanism is at least partially attached to the annulus partand at least partially attached to the ventricle part, for example, oneor more leaflets on the ventricle part and one or more leaflets on theannular part.

In some embodiments, the valve mechanism is suitable for functioning asa mitral valve even if not originally designed as a mitral valvereplacement, that is to say, to prevent flow of blood from the leftventricle to the left atrium through the prosthetic mitral valve lumenduring systole but to allow flow of blood from the left atrium to theleft ventricle during diastole. The valve mechanism can be any suitablevalve mechanism, some not necessarily limiting examples includemechanical valves such as; a bileaflet-mechanism (St. Jude mechanism), acaged-ball mechanism (e.g., Starr-Edwards mechanism), or a tilting-discmechanism (e.g., Bjork-Shiley mechanism). Alternatively, in someembodiments, the valve mechanism is a biological and/or syntheticleaflet-valve mechanism including at least two leaflets, in someembodiments at least three leaflets. Optionally, valves designed forreplacement of valves other than the mitral valve can be used, forexample, aortic replacement valves. Not necessarily limiting examplesinclude; Lotus™ or CoreValve™ mentioned above. Optionally, the valvemechanism, for example, the leaflet-valve mechanism, is located insidethe prosthetic mitral valve lumen. Optionally, the valve mechanism ispositioned within the prosthetic mitral valve lumen of the proximalportion, so that, when deployed, the valve mechanism is located withinthe native mitral valve annulus and/or inside the left ventricle of aheart in which deployed. Optionally, the position of the valve mechanismis positioned so that the trapped leaflets and the prosthetic valvemechanism acts as a seal to blood.

In some embodiments, the artificial valve mechanism, includingleaflet-valve mechanism is configured so as not to be subject toprolapse into a left atrium as can happen with native mitral valveleaflets. In some embodiments where a valve mechanism includes leafletsthat are potentially subject to prolapse, the prosthetic mitral valveoptionally includes a prolapse-preventing component, for example asdescribed in US 2002/0065554 and US 2004/0138745 or as implemented inthe Endovalve (Endovalve Inc., Princeton, N.J., USA). Alternatively,where a valve mechanism includes leaflets that are potentially subjectto prolapse, the prosthetic mitral valve optionally includes aprolapse-preventing component that is substantially an artificialchorda, for example as described in WO 2009/134701. Alternatively, noprolapse preventing component is used, for example if using a trileafletvalve design such as an aortic replacement valve.

Dynamic Conformation

In some embodiments, the annulus part of the prosthetic mitral valve isconfigured, (e.g., in the deployed configuration) to dynamically conformto the native mitral valve annulus and/or to the atrial walls inproximity of a native mitral valve of a heart in which deployed. Forexample, in some such embodiments, the annulus part is self-expandingand dimensioned to be slightly wider (radial dimension) than the nativemitral valve annulus and/or atrial walls of the heart in which deployedso that the annulus part is biased to radially expand against the atrialwalls and/or the native mitral valve annulus. Potentially, as the heartbeats and the shape and/or dimensions of the atrial walls and/or of thenative mitral valve annulus change (e.g., expansion and/or compression),the annulus part dynamically conforms, potentially assisting inmaintaining a seal between the left atrium and left ventricle and/orallowing substantially natural movement of the heart. Optionally, thevalve is made out of an elastic material which allows for the dynamicconformation, for example, Nitinol. Optionally or additionally, thevalve is designed with one or more features that allow for expansionand/or contraction, for example, within the struts, one or more ‘S’,‘Z’, or other similar shapes.

Expandable Annulus Part

In some embodiments, the annulus part is outwardly radially expandablefrom a compact delivery configuration to the deployed configuration.Optionally, the annulus part has a larger outer radius in the deployedconfiguration than in the delivery configuration, allowingminimally-invasive deployment of the prosthetic mitral valve, forexample, transapically, percutaneously, for example with the help of adeployment device such as a delivery catheter or similar.

In some embodiments, the annulus part is expandable from the deliveryconfiguration to the deployed configuration by application of a radiallyoutwards force to an inner surface thereof, for example, with acatheter-mounted balloon that can be expanded and retracted, forexample, by the operator outside of the body of the patient injectingfluid into the balloon. In one not necessarily limiting example, theannulus part is made out of a material that can be balloon expanded, forexample, stainless steel 316L.

In some embodiments, the annulus part is self-expanding from thedelivery configuration to the deployed configuration, for example, uponremoval of an encasing sheath. In one not necessarily limiting example,the annulus part is made out of a memory material, for example, Nitinol.

Expandable Ventricle Part

In some embodiments, the ventricle part is outwardly radially expandablefrom a compact delivery configuration to the deployed configuration.

Optionally, the ventricle part has a larger outer radius in the deployedconfiguration than in the delivery configuration, allowingminimally-invasive deployment of the prosthetic mitral valve, forexample, transapically, percutaneously, for example with the help of adeployment device such as a delivery catheter or similar.

In some such embodiments, the ventricle part is expandable from thedelivery configuration to the deployed configuration by application of aradially outwards force to an inner surface thereof, for example, with acatheter-mounted balloon.

In some such embodiments, the ventricle part is self-expanding from thedelivery configuration to the deployed configuration. Optionally, theannulus part and/or ventricle part are retractable, for example, byreplacing the encasing sheath. Potentially, the valve position isadjustable.

Connecting of the Two Parts

As noted above, in some embodiments the annulus part and the ventriclepart of the prosthetic mitral valve are two physically separatecomponents.

In some embodiments, the annulus part and the ventricle part areconfigured for mutual fixation in the deployed configurations, that isto say, when each part is in a deployed configuration and the prostheticmitral valve is deployed in a heart, the two parts can be fixed one tothe other. Optionally or additionally, the two parts are approximated(e.g., to align the parts) and then attached to one another. In someembodiments, the configuration comprises the presence of eyelets, gaps,tabs or the like allowing mutual fixation, optionally with the help ofan additional component, for example, a suture, attachment rings, tiesand the like, for example, as will be described below.

In some embodiments, the annulus part and the ventricle part aremateable in the deployed configuration, that is to say, the annulus partincludes one or more mating features configured to engage one or moremating features in the ventricle part. In some such embodiments, atleast one of the annulus part and the ventricle part includes bendingmating features, configured to be bent (in this context bent being anadjective, not a verb) when the annulus part and the ventricle part aremated (in this context, mated being an adjective not verb).

Tether

In some embodiments, the prosthetic mitral valve further comprises atleast one elongated tether (e.g., a string, a filament, a thread, forexample of non-dissolving suture material, polyethylene or PTFE)configured to assist in preventing the deployed prosthetic mitral valvefrom moving into the left atrium, for example, during systole.

In some embodiments, the prosthetic mitral valve further comprises atleast one elongated tether having a distal end functionally associatedwith the annulus part (e.g., tied, glued, crimped thereto) and aproximal end configured for securing in proximity of the apex of a heartin which deployed, for example, sutured, tied to an anchor. Potentially,the tether maintains the position of the valve under pressure in theannulus part (e.g., when valve is closed during systole) directed fromthe ventricle to the atrium assisting in preventing the annulus partfrom moving into the left atrium. In some cases, a force applied to theproximal end of the tether is at least partially transferred by theannulus part to an atrial surface near the mitral valve annulus.

In some embodiments, the prosthetic mitral valve further comprises atleast one elongated tether having a distal end functionally associatedwith the ventricle part (e.g., tied, glued, crimped thereto) and aproximal end configured for securing in proximity of the apex of a heartin which deployed (e.g., sutured, tied to an anchor), wherein a portionof the tether passes through the annulus part (e.g., loops through,slidingly associated with) so that tension (or other force) applied fromthe proximal end of the tether (e.g., by the securing to the apex) pullsthe ventricle part towards the annulus part. Optionally, the force is atleast partially transferred by the annulus part to an atrial surfacenear a native mitral valve annulus in which deployed. Potentially, thetether assists in preventing the annulus part from moving into the leftatrium.

Optionally, the same tether is used to anchor the annulus part and theventricle part. Alternatively, different tethers are used, for example,at least one tether to anchor the annulus part and at least onedifferent tether to anchor the ventricle part.

Any suitable elongated tether may be used, for example, a string, afilament or a thread, for example of non-dissolving suture material,polyethylene or PTFE.

Optionally, the distal end of a tether is secured (for example, by tyingor fastening) to the part of the prosthetic mitral valve to befunctionally associated therewith.

Optionally, the distal end of a tether is configured for securing inproximity of the apex of a heart in which deployed by being securable toan anchor penetrating into the cardiac muscle (for example, as disclosedin PCT patent publication WO2007/135101) or by being configured to passthrough the cardiac muscle to be secured to a pad that contacts theouter surface of the heart, e.g., such as pads commercially-availablewith the Coapsys® device from Myocor, Inc., Maple Grove, Minn., USA.

Delivery Device for a Prosthetic Mitral Valve

Embodiments of the prosthetic mitral valve disclosed herein may bedeployed using any suitable method, including open-heart surgery andminimally-invasive surgery, for example with a deployment device such asa flexible catheter that enters the left ventricle through thevasculature and the aorta, with a deployment device such as a catheterthat enters the left atrium through the roof of the left atrium ortranseptallly from the right atrium, and/or transapically with adeployment device such as a transapical catheter that enters the leftventricle through the cardiac apex.

In an exemplary embodiment of the invention, the prosthetic mitral valveis transapically deployed using a deployment device, for example, asdescribed herein.

According to an aspect of some embodiments of the invention there isprovided a deployment device for transapically deploying a prostheticmitral valve contained therein, comprising:

a) a substantially tubular delivery housing including a delivery lumenhaving an opening at a distal end thereof, the delivery housingconfigured for transapical entry into a mammalian heart the distal endfirst;

b) inside the delivery lumen, an annulus part of a prosthetic mitralvalve (substantially as described above) defining a prosthetic mitralvalve lumen and having a proximal portion, in a compact deliveryconfiguration, the annulus part outwardly radially expandable,subsequent to release from the delivery housing, to a deployedconfiguration configured for deployment inside a left atrium of a heartin which deployed wherein the proximal portion passes into (and in someembodiments through) the mitral valve annulus of the heart;

c) inside the delivery lumen, proximally from the annulus part, aventricle part of a prosthetic mitral valve (substantially as describedabove) physically separate from the annulus part, in a compact deliveryconfiguration, the ventricle part outwardly radially expandable,subsequent to release from the delivery housing, to a deployedconfiguration configured for deployment in a left ventricle of a heartat least partially encircling the proximal portion of the annulus part;

d) an annulus-part release component (in some embodiments, activatablefrom a proximal end of the delivery housing) allowing release of theannulus part through the distal end of the delivery housing;

e) a ventricle-part release component (in some embodiments, activatablefrom a proximal end of the delivery housing) allowing release of theventricle part through the distal end of the delivery housing; and

f) a joining component functionally associated with the annulus part andthe ventricle part of the prosthetic mitral valve, the joining componentconfigured to bring the annulus part and the ventricle part togetherwhen the annulus part is in the deployed configuration subsequent torelease from the delivery housing, allowing deployment of the prostheticmitral valve in a heart.

In some embodiments, the annulus part includes a valve mechanismfunctionally associated with the prosthetic mitral valve lumen, thevalve mechanism suitable for functioning as a mitral valve.

Balloon-Expandable Annulus Part

In some embodiments, the deployment device further comprises anannulus-part expansion assembly, configured to apply a radially outwardsforce to an inner surface of the annulus part subsequent to release fromthe delivery housing to radially expand the annulus part from thedelivery configuration to the deployed configuration, for example, theannulus-part expansion assembly includes a catheter-mounted ballooncatheter.

In some such embodiments, the annulus part and the annulus-partexpansion assembly are together configured so that in the deployedconfiguration, the annulus part conforms to an atrial contour near anative mitral valve in which deployed, for example, when theannulus-part expansion assembly is a catheter-mounted balloon, theballoon has an inflated shape similar to the atrial contour near thenative mitral valve, and/or the balloon is a compliant balloon thatadopts the shape of the atrial contour near the native mitral valve wheninflated. Alternatively or additionally, the balloon is shaped accordingto the desired deployment shape of the annulus part, for example, havingthe funnel shape as previously described.

Self-Expanding Annulus Part

In some embodiments, the annulus part is self-expanding from thedelivery configuration to the deployed configuration subsequent torelease from the delivery housing. In some such embodiments, the annuluspart is configured so that in the deployed configuration, the annuluspart dynamically conforms to a mitral valve annulus and/or to atrialwalls in proximity of the mitral valve of a heart in which deployed, asdescribed above.

Balloon-Expandable Ventricle Part

In some embodiments, the deployment device further comprises aventricle-part expansion assembly, configured to apply a radiallyoutwards force to an inner surface of the ventricle part subsequent torelease from the delivery housing to radially expand the ventricle partfrom the delivery configuration to the deployed configuration, forexample, the ventricle-part expansion assembly includes acatheter-mounted balloon catheter.

Self-Expanding Ventricle Part

In some embodiments, the ventricle part is self-expanding from thedelivery configuration to the deployed configuration subsequent torelease from the delivery housing.

Tether

In some embodiments, the deployment device further comprises, inside thedelivery lumen, at least one elongated tether of a prosthetic mitralvalve (as described above), the at least one elongated tether having adistal end functionally associated with the annulus part of theprosthetic mitral valve and a proximal end configured for securing inproximity of the apex of a heart in which deployed, so that a forceapplied to the proximal end of the tether is at least partiallytransferred by the annulus part to an atrial surface near a nativemitral valve annulus in which deployed.

In some embodiments, the deployment device further comprises, inside thedelivery lumen, at least one elongated tether of a prosthetic mitralvalve (as described above), the at least one elongated tether having adistal end functionally associated with the ventricle part of theprosthetic mitral valve and a proximal end configured for securing inproximity of the apex of a heart in which deployed, wherein a portion ofthe tether passes through the annulus part of the prosthetic mitralvalve so that force applied to the proximal end of the tether pulls theventricle part towards the annulus part, and is at least partiallytransferred by the annulus part to an atrial surface near a nativemitral valve annulus in which deployed.

Annulus Part Placement Component

In some embodiments, the deployment device further comprises anannulus-part placement component functionally associated with theannulus part of the prosthetic mitral valve, configured to assist inproperly positioning the annulus part in a native mitral valve annuluswhen in the deployed configuration. In some embodiments, theannulus-part placement component is functional to pull and/or push theannulus part proximally from the volume of the left ventricle (in whichthe annulus part was expanded to the deployed configuration) into themitral valve annulus. In some embodiments, the annulus-part placementcomponent is an elongated component, rigid (e.g., a rigid wire) orflexible (e.g., a filament, string or thread), having a distalfunctionally associated with (e.g., secured, temporarily or permanently)the annulus part and a proximal end that is accessible from the proximalend of the delivery housing, e.g. for pulling or pushing.

In some embodiments, the annulus-part placement component is configuredto also function as a deployable tether, substantially as describedabove.

Mater Component

As discussed above, in some embodiments, the annulus part and theventricle part are configured for mutual fixation in the deployedconfigurations.

In some such embodiments, the annulus part and the ventricle part aremateable in the deployed configurations. Optionally, the annulus partincludes a first mating feature configured to engage a second matingfeature in the ventricle part. Optionally, the deployment device furthercomprises a mater component, configured to assist in effecting themating of the annulus part and the ventricle part. In some embodiments,the role of the mater is performed by a joining component, discussedbelow.

In some such embodiments, at least one of the annulus part and theventricle part include a bending mating feature, configured to be bentwhen the annulus part and the ventricle part are mated (as discussedabove). Optionally, the mater component is configured to bend thebending mating features. In some embodiments, the role of the mater isperformed by a joining component, discussed below.

Joining Component

As noted above, in some embodiments, the deployment device comprises ajoining component functionally associated with the annulus part of theprosthetic mitral valve and/or with the ventricle part of the prostheticmitral valve, the joining component configured to bring the annulus partand the ventricle part together when the annulus part is in the deployedconfiguration. In an exemplary embodiment of the invention, the joiningcomponent is configured to perform one or more functions including:

-   -   to function as a ventricle-part release component, e.g.,        functional for removing (e.g., by pulling) the ventricle part        out of the delivery housing through the distal opening of the        delivery housing.    -   to function as an annulus-part placement component, e.g.,        functional for pulling the annulus component into a native        mitral valve annulus, substantially as described above.    -   to function as a deployable tether, substantially as described        above.    -   to function as a mater component, substantially as described        above, for example, configured to bend mating features of at        least one of the annulus part and the ventricle part, thereby        mating the two parts.

In some embodiments, the joining component comprises at least oneelongated flexible component that is slidingly associated with (e.g.,loops around) a portion of the annulus part. Optionally, a proximal endis accessible from a proximal end of the delivery housing (e.g., forpulling), and a distal end secured to the ventricle part. Any suitableelongated flexible component may be used, for example, a string, afilament or a thread, for example of non-dissolving suture material,polyethylene or PTFE. Optionally, the distal end of the joiningcomponent is secured (for example, by tying or fastening) to theventricle part.

In some such embodiments, the joining component is releasably secured tothe ventricle part, for example, the joining component is released fromthe ventricle part after deployment. In some such embodiments, thejoining component is fixedly secured (e.g., permanent) to the ventriclepart, for example allowing the joining component to serve as a tether.

Parts of an embodiment of a prosthetic mitral valve as described herein,prosthetic mitral valve 50, are schematically depicted in FIGS. 2A and2B, in accordance with an exemplary embodiment of the invention. InFIGS. 2A and 2B, an annulus part 52 and a ventricle part 54 aredepicted. Optionally, parts 52 and 54 are physically separate anddistinct. Optionally, parts 52 and/or 54 are fashioned of self-expandingmaterial, for example, nitinol. Optionally, parts 52 and/or 54 arebiased to a larger outer radius deployed configuration. In one example,parts 52 and/or 54 are substantially self-expanding stents, laser-cutfrom a 10 mm outer diameter 1 mm thick tube of nitinol.

In an exemplary embodiment of the invention, annular portion 52comprises a valve mechanism 350, for example, as described in thesection “valve mechanism”.

In FIG. 2A, annulus part 52 and ventricle part 54 are depicted in acompact delivery configuration, for example, as if held inside adelivery lumen of a delivery housing (e.g., of a deployment device suchas a valve-deployment catheter), The length of annulus part 52 is, forexample, about 20 mm long, or about 24 mm, or about 26 mm, or about 30mm, or about 34 mm, or about 38 mm, or about 42 mm, or about 46 mm, orabout 50 mm, or other smaller, intermediate or longer length. The lengthof ventricle part 54 is, for example, about 6 mm long, or about 8 mm, orabout 10 mm, or about 12 mm, or about 14 mm, or about 16 mm, or about 20mm, or other smaller, intermediate or larger sizes.

Annulus part 52 defines a prosthetic mitral valve lumen 66 that passesthrough annulus part 52 between a proximal end 56 and a distal end 60.

Optionally, annulus part 52 is divided into two portions betweenproximal end 56 and distal end 60, a proximal portion 62 and a distalportion 64. Optionally, distal portion 64 is entirely defined by struts.Optionally or additionally, the distal part of proximal portion 62 isdefined by struts while the proximal part is optionally defined by oneor more attachment elements adapted to connect to the ventricle part.For example, 1, 3, 5, or other number of attachment elements. Forexample, perforated tabs 58. The length of tabs 58 is, for example,about 10 mm, about 7 mm, about 5 mm, or other smaller, intermediate orlarger lengths. Optionally, the attachment elements are spread aroundthe circumference, for example, about evenly around.

Amongst other functions, tabs 58 constitute configuration of annuluspart 52 for mutual fixation of annulus part 52 and ventricle part 54.Other not necessarily limiting examples of attachment elements include;eyelets, gaps, latches.

In some embodiments, attachment elements 300 are adapted for directlygrabbing or attaching annulus part 52 to ventricle part 54. Optionally,elements 300 are located on annulus part 52. Alternatively oradditionally, elements 300 are located on ventricle part 54. Optionally,attachment elements 300 are finger like extensions oriented so that whenventricle part 54 is approximated with atrial part 52, struts ofventricle part 54 are positioned between the fingers of attachmentelements 300. Optionally, elements 300 are bendable, for example, byusing a device such as a surgical clamp, fingers of elements 300 can bebent around struts of ventricle part 54 to maintain the approximatedposition. Alternatively or additionally, elements 300 are one wayclasps, so that once struts of ventricle part 54 enter the claps, thestruts cannot leave.

In an exemplary embodiment of the invention, disposed inside lumen 66 isa pericardial trileaflet valve mechanism 67. Optionally, valve 67 issecured to the struts making up the distal part of proximal portion 62.

Ventricle part 54 has a distal end 68 and a proximal end 70.

In FIG. 2B, annulus part 52 and ventricle part 54 are depictedunconstrained and adopting a deployed configuration, in accordance withan exemplary embodiment of the invention.

In an exemplary embodiment of the invention, annulus portion (e.g., inthe expanded state) has a funnel-like shape (e.g., having a narrower(axial dimension) proximal portion and a wider (axial dimension) distalportion). Alternatively, a cylindrical shape, or other shapes are used.An outer diameter at distal end 60 is, for example, about 30 mm, orabout 34 mm, or about 38 mm, or about 42 mm, or about 48 mm, or about 52mm, or other smaller, intermediate or larger diameters. The outerdiameter at proximal end 56 is, for example, about 19 mm, or about 23mm, or about 27 mm, or about 31 mm, or about 35 mm, or other smaller,intermediate or larger sizes. The total length of annulus part 52 is,for example, about 20 mm, or about 24 mm, or about 28 mm, or about 32mm, or other smaller, intermediate or larger lengths. Optionally, thelength of proximal portion 62 (comprising the replacement leaflets) is,for example, about 10 mm, or about 14 mm, or about 18 mm, or othersmaller, intermediate or larger lengths. Optionally, the length ofportion 62 includes an additional length of tabs 58 (the tabs describedbelow). Alternatively, the overall length already includes the tabs 58.Alternatively, the tabs 58 do not extend part end of portion 62, forexample, incorporated therein.

In some embodiments, the size and/or shape of annulus part 52 is suchthat annulus part 52 is configured for deployment inside a left atriumof a heart wherein proximal portion 62 passes into a mitral valveannulus and tabs 58 extend into the left ventricle of the heart and atleast partially beyond the native mitral valve leaflets, while the outersurface of distal portion 64 snugly rests against the inner walls of theleft atrium in proximity of the mitral valve annulus.

In an exemplary embodiment of the invention, the cross section ofventricle part 54 is approximately trapezoidal, potentially the shapearound the native leaflets. Alternatively, other shapes are used, forexample, circles, ellipses. In some embodiments, the ventricle part 54of the prosthetic mitral valve has a diameter larger than that of thenative mitral valve orifice. Alternatively, the diameter is smaller thanthe native mitral valve orifice. The outer diameter at distal end 68and/or proximal end 70 is, for example, about 24 mm, about 28 mm, about32 mm, or about 36 mm, or about 40 mm, or about 44 mm, or other smaller,intermediate or larger sizes. Optionally, the diameters of ends 68 and70 are different, to create a tapered or cone-like configuration. Thelength of portion 206 is, for example, about 6 mm, or about 10 mm, orabout 14 mm, or other smaller, intermediate or larger sizes.

In an exemplary embodiment, the size and/or shape of ventricle part 54is such that when annulus part 52 is deployed inside a left atrium of aheart as described above, ventricle part 54 can be placed over so as toencircle proximal portion 62 of annulus part 52 and the native mitralvalve leaflets of the heart.

In an exemplary embodiment of the invention, the valve is designed tofit within a wide range of mitral valve annulus diameters, for example,children, patients with dilated ventricles and/or atria, patients havingundergone previous mitral valve surgery and/or cardiac reconstructivesurgery.

As noted above, pericardial trileaflet valve mechanism 67 is disposedinside lumen 66 and is secured to the struts making up proximal portion62 of annulus part 52, for example, valve 67 is sewed, glued, crimpedand/or dip-moulded onto annulus part 52. Valve mechanism 67 is orientedin a direction so that when annulus part 52 is in a deployedconfiguration as depicted in FIG. 2B, valve mechanism 67 is functionalfor allowing the flow of blood from distal end 60 to proximal end 56through lumen 66. Optionally or additionally, valve 67 is oriented forblocking the retrograde flow of blood from proximal end 56 to distal end60 through lumen 66. In such a way, valve mechanism 67 is functionallyassociated with lumen 66 in a manner suitable for functioning as amitral valve.

In an exemplary embodiment of the invention, the diameter of annulusportion 52 housing replacement valve 67 is, for example, about 12 mm,about 14 mm, about 16 mm, about 18 mm, about 20 mm, about 22 mm, about24 mm, about 26 mm, about 28 mm, about 30 mm, about 32 mm, about 34 mm,about 36 mm, about 38 mm, about 40 mm, or other smaller, intermediate orlarger diameters. In some embodiments, a variety of sizes are availablefor different patient groups. Some not necessarily limiting examples offactors affecting the selection of the size include; age of patient(e.g., pediatric vs adult), mitral valve annulus size (e.g., normal vsdilated, native valve vs prosthetic valve or annuloplasty).Alternatively, only a small number of sizes are available, for example,one size is available for adults regardless of the mitral valve annulussize, as the amount of leaflets squeezed is varied to fit in thedifferent annulus sizes. For example, in a patient with a largerannulus, less leaflet area is squeezed than in a patient with a smallerannulus.

In an exemplary embodiment of the invention, a height of part 52 is longenough to attach to valve 67. Optionally or additionally, the height islong enough to provide anchoring against the leaflets. The height is,for example, at least 5 mm, or at least 7 mm, or at least 10 mm, or atleast 15 mm, or at least 20 mm, or other smaller, intermediate or largervalues are used.

In an exemplary embodiment of the invention, proximal portion 62 ofportion 204 is long enough to pass into the ventricle when deployed inthe mitral valve annulus, for example, tabs 58 extend into theventricle. Alternatively, portion 62 does not extend past the annulusinto the ventricle.

In FIG. 2B is also depicted one or more filaments 72 that are configuredto act as a joining component to bring annulus part 52 and ventriclepart 54 together when in a deployed configuration. Optionally, thedistal ends of filament 72 are secured (e.g., by tying, gluing,crimping) to struts of ventricle part 54. Optionally, filament 72 loopsaround a portion of annulus part 54 (e.g., through perforations in tabs58, around and/or through struts). Operation of filament 72 as a joiningcomponent is discussed in detail hereinbelow.

In FIG. 3, an embodiment of a deployment device, 74, for deploying aprosthetic mitral valve 50 contained therein is schematically depictedin side cross section, in accordance with an exemplary embodiment of theinvention. Device 74 is designed for deployment of the valve byplacement of the device in the left ventricle, for example, using atransapical approach, or a vascular approach via the aorta. Optionally,deployment device 74 comprises a substantially tubular delivery housing76. Optionally, device 74 includes a delivery lumen 78 having a distalopening 80 at a distal end 82 thereof. Optionally or additionally,device 74 includes a proximal opening 84 at a proximal end 86 thereof.In some embodiments, Delivery housing 76 is fashioned of biocompatiblematerials and in a manner known in the art to allow minimally invasive(e.g., transapical or percutaneous) entry into a human heart distal end82 first.

In an exemplary embodiment, annulus part 52 of prosthetic mitral valve50 is held inside delivery lumen 78 in a compact delivery configuration,optionally, near distal opening 80.

Optionally, contacting the proximal ends (e.g., tabs 58) of annulus part52 is a distal end 88 of an optional push rod 90. Optionally, push rod90 extends proximally, exiting delivery lumen 78 from proximal opening84 through an optional first passage in an optional sterility preservingsealing ring 92. As is discussed below, push rod 90 constitutes anannulus-part release component that is optionally activatable fromproximal end 86 of delivery housing 76, for example, by slidinglypushing push rod 90 in a distal direction. Optionally, push rod 90 ismanually activated, for example, by the operator. Alternatively, pushrod 90 is automatically activated, for example, by a robot.

Optionally or additionally, a ventricle part 54 of prosthetic mitralvalve 50 is held inside delivery lumen 78 in a compact deliveryconfiguration, optionally, proximally to distal end 88 of push rod 90and optionally surrounding push rod 90.

In some embodiments, annulus 52 and ventricle 54 are physically separateand housed in one tube. Alternatively, two separate delivery tubes areused, one housing annulus 52 and one housing ventricle 54.

In some embodiments, the delivery device is sold pre-assembled andloaded with the selected prosthetic valve. Alternatively, the deliverydevice is assembled by the physician before the procedure, for example,the delivery device is standard, and the valve is variable. In such acase, the physician may fill the lumen with fluid (e.g., saline) beforedelivery.

In some embodiments, an optional filament 72 is also held insidedelivery lumen 78. For clarity, and as noted above, details of filament72 will be discussed with reference to FIG. 2B.

Optionally, a proximal end 94 (FIG. 3) of filament 72 comprises a singlestrand, for example, made of flexible ultrahigh molecular weightpolyethylene (UHMWPE). Optionally, proximal end 94 of filament 72extends proximally, exiting delivery lumen 78 from proximal opening 84through an optional second passage in optional sterility preservingsealing ring 92.

Optionally, near a distal end 96 (and as seen in FIG. 2B), filament 72comprises, for example, two, three, five or other number of (e.g.,separate) strands (e.g., of UHMWPE) attached (e.g., tied, glued,crimped) to the proximal strand (e.g., single strand). Each one of theseparate strands loops around a portion of annulus part 52 (for example,through a perforation in a tab 58) so that the separate strands canslidingly move therethrough. Optionally, one or more of the separatestrands are secured (e.g. by tying, gluing, crimping) around an element(e.g., strut) and through a gap in the side of ventricle part 54 so thatthe strands are distributed (e.g., equally) around the periphery ofventricle part 54.

In some embodiments, filament 72 and tabs 58 together constitute partsof a ventricle-part release component. Optionally, the ventricle releasecomponent is activatable (e.g., by the user), for example, from proximalend 86 of delivery housing 76. Optionally or additionally, filament 72and tabs 58 constitute parts of a joining component configured to bringannulus part 52 and ventricle part 54 together, for example, whenannulus part 52 is in a deployed configuration, for example, subsequentto release from delivery housing 76.

Optionally or additionally, filament 72 and tabs 58 constitute parts ofan annulus-part placement component configured to assist in properlypositioning annulus part 52 in a native mitral valve annulus, forexample, when in a deployed configuration. Optionally or additionally,the parts constitute parts of a deployable tether, for example, asdescribed herein.

In some embodiments, the empty volume of delivery lumen 78 is filledwith a sterile preservative solution (e.g., glutaraldehyde solution) tomaintain the valve mechanism of prosthetic mitral valve 50 sterile andready for use.

Optionally, a cap 98 seals distal opening 80, potentially preventing orreducing loss of the preservative solution and of sterile conditionsinside delivery lumen 78.

Exemplary Deployment Method

FIG. 6 is a flowchart of a method for deploying a prosthetic mitralvalve, using the deployment device, in accordance with an exemplaryembodiment of the invention. Optionally, the trans-apical approach isused. However, the method is applicable to other approaches, forexample, trans-vascular approaches through the aorta into the leftventricle. To help understand the method, reference will also be made toFIGS. 4A-4H which graphically illustrate the method as applicable toself expanding annulus part 52 and ventricle part 54. To help understandthe method, reference will also be made to FIGS. 5A-5G which illustratethe method as applicable to annulus part 52 and ventricle part 54 thatare expandable to application of an outward radial force.

In some embodiments, at least some of the procedure is performed underfluoroscopic guidance.

Optionally, at 802 and/or at 4A, access to the heart is obtained, forexample, by apex 48 puncture. Alternatively, access to the heart isobtained using a vascular approach, for example, obtaining access in thefemoral artery, and threading a guidewire and/or catheter to the heartthrough the aorta, or from the femoral artery, into the right atrium,and after making a septal puncture to the left atrium. Optionally, aguide wire 100 (e.g., soft and/or flexible) is passed retrograde acrossnative mitral valve 26 (e.g., regurgitant or other defects).

Optionally, at 806, delivery device 74 and/or 106 is prepared.Optionally, cap 98 of deployment device 74 is removed. Optionally oradditionally, the preservative solution is washed out of delivery lumen78. Optionally or additionally, the solution is replaced with salinewhile ensuring adequate degassing of delivery lumen 78.

In some embodiments, deployment device 74 is guided distal end firstalong guide wire 100 until distal opening 80 is located inside leftatrium 24, for example, across mitral annulus 34. Optionally, guide wire100 is withdrawn (FIG. 4B, FIG. 5A).

At 808 and/or FIG. 4C, the annular component is deployed. Optionally,push rod 90 (see back to FIG. 3) is pushed distally to function as anannulus-part release component. Optionally, rod 90 pushes annulus part52 out of delivery housing 76, for example, through distal opening 80,into the volume of left atrium 24.

In some embodiments, once released from the confines of delivery housing76, annulus part 52 self-expands to adopt a deployed configurationinside left atrium 24. In some embodiments, annulus part 52 remainsassociated with delivery housing 76, for example, through filament 72.

Alternatively in some embodiments, as shown in FIG. 5B, rigid ballooninflation tube 108 is pushed forward to function as an annulus-partrelease component. Optionally, tube 108 carries annulus part 52 crimpedon distal balloon 110 out of delivery housing 76 into the volume of leftatrium 24. Optionally or additionally, tube 108 functions as aventricle-part release component. Optionally, tube 108 carries ventriclepart 54 crimped on proximal balloon 112 out of delivery housing 76 intothe volume of left ventricle 28.

In some embodiments, inflation fluid (e.g., saline) is forced throughone lumen of balloon inflation tube 108, inflating distal balloon 110and thereby expanding annulus part 52 inside left atrium 24. In suchembodiments, distal balloon 110 functions as a component of anannulus-part expansion assembly. Optionally, the inflation fluid iswithdrawn, deflating distal balloon 110 (FIG. 5C).

In some embodiments, the annulus part 52 comprises one or more piercingelements adapted to pierce the leaflets, for example, upon expansion ofannulus part 52. Alternatively or additionally, the piercing elementsare adapted to pierce surrounding tissues, for example, the fibrous ringand/or the atrium wall. Not necessarily limiting examples of piercingelements include; barbs, hooks, needles. Potentially, the piercingelements help anchor annulus part 52 to the leaflets and/or surroundingtissues.

At 810 and/or FIG. 4D, the annular component is approximated with thenative mitral valve annulus.

In some embodiments, deployment device 74 is withdrawn in a proximaldirection so that distal opening 80 is located inside left ventricle 28.

Optionally, proximal end 94 of filament 72 is pulled proximally so thatfilament 72 functions as an annulus-part placement component, pullingannulus part 52 to a properly deployed position in mitral valve annulus34.

Optionally, proximal portion 62 of annulus part 54 is directed intomitral valve annulus 34. Optionally or additionally, a portion thereof(e.g., tabs 58) passes through mitral valve annulus 34, into leftventricle 28, and optionally past the edges of mitral valve leaflets 38and 40. Alternatively, in some embodiments as shown in FIG. 5D, proximalend of filament 72 is pulled proximally through the proximal end ofdelivery housing 76 while balloon inflation tube 108 is held in place.In such embodiments, filament 72 functions as the annulus-part placementcomponent, pulling annulus part 52 to a properly deployed position inmitral valve annulus 34.

Optionally at 812, the position of annulus part 52 in mitral valveannulus 34 is confirmed, for example, by imaging (e.g., fluoroscopy,ultrasound).

Optionally, at 804, the chordae are disconnected from papillary muscles(both not depicted in FIG. 4 for clarity), for example by cutting with atool that is guided along guide wire 100 or is inserted through the apexincision, such as a knife.

In practice, once the annular component has been deployed, leaflets willremain in the ventricle even if cords are removed, as the leaflets willbe held in position by the annular part against the mitral valveannulus, being prevented from prolapsing back into the atrium by theannular component. Alternatively, some of the cords are disconnected andsome are left intact, for example, if using the ventricle component thatis a partial ring.

Alternatively, in some embodiments, the chords are not cut. Optionally,the embodiment of the partial-circumference ventricle component is used.

At 814 and/or FIG. 4E, the ventricular component is deployed.Optionally, filament 72 (e.g., proximal end 94 thereof) is pulledproximally to function as a ventricular-part release component.Optionally, filament 72 pulls ventricle part 54 out of delivery housing76, for example, through distal opening 80 into the volume of leftventricle 28.

In some embodiments, once released from the confines of delivery housing76, ventricle part 54 self-expands to adopt a deployed configurationinside left ventricle 28.

Alternatively, in some embodiments and as illustrated in FIG. 5E,inflation fluid is forced through the second lumen of balloon inflationtube 108, inflating proximal balloon 112 and thereby expanding ventriclepart 54 inside left ventricle 28. In such embodiments, proximal balloon112 functions as a component of the ventricle-part expansion assembly.Optionally, the inflation fluid is withdrawn, deflating proximal balloon112.

At 816 and/or FIG. 4F or FIG. 5F, the annular and ventricle portions areapproximated.

Optionally in some embodiments, the approximation is performed by anapproximating and/or joining component. Optionally, proximal end 94 offilament 72 is pulled proximally even further than in box 814.Optionally, filament 72 functions as an approximating component,positioning annulus part 52 and ventricle part 54 in close proximity.Optionally or additionally, filament 72 functions as a joiningcomponent, pulling ventricle part 54 over at least a portion of mitralvalve leaflets 38 and/or 40 and/or over proximal portion 62 of annuluspart 52. Optionally or additionally, ventricle part 54 at leastpartially encircles portions of proximal portion 62 of annulus part 52,(e.g., tabs 58) as well as mitral valve leaflets 38 and/or 40.

In some embodiments, one filament branches out into multiple attachmentlocations on annulus 52. Potentially, pulling on the one filament movesand/or approximates annulus 52 with ventricle 54. Alternatively, eachattachment location is associated with an independent filament, and eachfilament requires pulling. Potentially, the multiple filaments allowincreased control over the approximation, as pulling the differentfilaments associated with locations around annulus 52 can tilt thevalve, or move the valve in a radial direction.

In some embodiments, the pulling anchors the prosthetic valve toleaflets 38 and/or 40 between ventricle part 54 and annulus part 52(e.g., proximal portion 62).

Alternatively, in some embodiment, the approximation is performed byusing one or more balloons (note that the balloons can be used even inembodiments in which ventricle part 54 and/or annulus part 52 are selfexpanding). Optionally, a first balloon is expanded inside the expandedannuls part 52. In the embodiment in which annulus part 52 is funnelshaped, the first balloon prevents distal movement of annulus part 52into the left ventricle. Optionally or additionally, a second balloon isexpanded inside the expanded ventricle part 54. Optionally, the secondballoon is wider proximally, wider than the diameter of ventricle part54, to prevent distal movement of ventricle part 54 into the leftventricle. Optionally, the expanded balloons are used to guide and/ormove the annulus part 52 and/or ventricle part 54. For example, theoperator can proximally pull the first balloon and distally push thesecond balloon, thereby approximating annulus part 52 and ventricle part54.

Optionally, at 822, filaments 72 are tied together, in accordance withsome embodiments of the invention. Optionally, filament 72 isprearranged for easy tying, for example, having a pre-existing knot thatrequires tightening to secure the tying.

Optionally, at 818 and/or FIG. 4G, the relative positions of atrial part52 and ventricle part 54 are set so that relative movement is reducedand/or prevented.

In some embodiments, ventricle part 54 comprises one or more piercingelements adapted to pierce the leaflets. Optionally or additionally, thepiercing elements are adapted to pierce surrounding tissues, forexample, the fibrous ring and/or ventricle wall. Optionally, thepiercing occurs upon moving ventricle part 54 towards atrial part 52.Potentially the piercing elements help to grab on to the leaflets, andhelp to set the relative positions of atrial part 52 and ventricle part54.

Optionally, balloon inflation tube 108 is withdrawn from deliveryhousing 76 in a proximal direction.

Optionally, a crimping tool 102 (e.g., surgical clamp) and/or videocamera 103 (e.g., fiber-optic) are advanced into delivery lumen 78, forexample, through suitable ports in sealing ring 92 of deployment device76, and/or through a different access route (e.g., through thevasculature using trans-catheter techniques). Optionally, crimping tool102 is advanced to proximity with ventricle part 54, for example,through delivery lumen 78 of delivery housing 76. Optionally, tool 102(e.g., under guidance of a fiber-optic video camera 103 and/or echoand/or fluoroscopy) is used to crimp connectors 105 (e.g., 1, 3, 5, orother numbers) around the distal ends of filament 72 (e.g., 1, 3, 5, orother numbers) (e.g., near the inner face of tabs 58). Optionally, thecrimping fixes the relative positions between annulus part 52 andventricle part 54. Alternatively or additionally, tool 102 is used tocrimp attachment elements 300, for example, by bending the fingers ofelements 300 so that the edges of the fingers overlap one another and‘grab’ the struts of ventricle part 54.

Optionally crimping tool 102 and/or video camera 103 are withdrawn fromthe delivery lumen of delivery housing 76.

Optionally, a cutting tool is inserted and is used to clip the distalends of filament 72, for example, close to crimped connectors 105.Optionally, the cutting tool and the thus-released portion of filament72 are withdrawn from left ventricle 28 in a proximal direction.Alternatively, filament 72 remains secured to deployed prosthetic mitralvalve 104. Optionally, proximal end 94 trails out of heart 10 throughthe incision in apex 48. Optionally, the incision is closed in the usualway.

In some embodiments, filament 72 remains secured to deployed prostheticmitral valve 104 with proximal end 94 trailing out of heart 10 throughthe incision in apex 48. Optionally, proximal end 94 of filament 72 issecured, for example, to a pad 114 that contacts outer surface 116 ofheart 10, for example, commercially-available pads with the Coapsys®device from Myocor, Inc., Maple Grove, Minn., USA. In some embodiments,filament 72 functions as a tether, assisting in preventing prostheticmitral valve 104 from moving into left atrium 24, (FIG. 5G).

Optionally, at 820 and/or FIG. 8H, the procedure is ended. Optionally,delivery housing 76 is withdrawn from heart 10.

In some embodiments, prosthetic mitral valve 50 is deployed in heart 10,surrounding native mitral valve annulus 34, grabbing at least some ofleaflets 38 and/or 40 from above with annulus part 52 and from belowwith ventricle part 54.

Once the operation is complete, deployed prosthetic mitral valve 50functions as a patent mitral valve. Potentially, the self-expandingproperties of annulus part 52 and/or ventricle part 54 allow dynamicconformation to the shape and/or size of mitral valve annulus 34 and/orthe atrial walls as these change during the beating of heart 10,potentially allowing parts 52 and/or 54 to adopt a smaller configurationwhen mitral valve annulus 34 compresses and/or to spring back to alarger-sized configuration when mitral valve annulus 34 relaxes.

In the embodiment discussed above with reference to FIGS. 3 and 4,annulus part 52 and ventricle part 54 are self-expanding from a deliveryconfiguration to a deployed configuration. In some embodiments, one orboth of an annulus part and a ventricle part of a prosthetic mitralvalve as described herein are expandable from a delivery configurationto a deployed configuration by application of a radially outward forceapplied to an inner surface thereof. In a not necessarily limitingexample, the radially expandable portions are made for example, fromsteel 316L. Specifically, in some embodiments, an annulus part isself-expanding and a ventricle part is expandable by application of anoutwards radial force. In a not necessarily limiting example, theradially expandable portion is made for example from steel, and the selfexpanding portion is made for example from Nitinol, with the portionsattached together, for example, by welding, gluing, crimping or othermethods. Alternatively, a ventricle part is self-expanding and anannulus part is expandable by application of an outwards radial force.Alternatively, both an annulus part and a ventricle part are expandableby application of an outwards radial force. Alternatively, annulusand/or ventricle parts are not expandable, for example, for surgicalimplantation. In such a case, other materials can be used, for example,polyurethane.

In some embodiments, the method of FIG. 6 is used to deliver theradially expandable embodiments of annulus part 52 and ventricle part54. In FIGS. 5A-5G are depicted the deployment of a prosthetic mitralvalve as described herein, prosthetic mitral valve 104, that issubstantially similar to prosthetic mitral valve 50 described aboveexcept that both an annulus part 52 and a ventricle part 54 areexpandable by application of an outwards radial force. In someembodiments, deployment is performed using an embodiment of a deploymentdevice as described herein, deployment device 106,

Optionally, at 802, deployment begins as described above for prostheticmitral valve 50. Optionally, deployment device 106 is advanced so thatdistal opening 80 is located in left ventricle 28 across mitral valveannulus 34, FIG. 5A.

At 808, (e.g., rigid) balloon inflation tube 108 is pushed forward tofunction as an annulus-part release component. Optionally, tube 108carries annulus part 52 (e.g., crimped on distal balloon 110) out ofdelivery housing 76 into the volume of left atrium 24.

At 810, a proximal end of filament 72 is pulled proximally (e.g.,through the proximal end of delivery housing 76) while balloon inflationtube 108 is held in place. Optionally, filament 72 functions as anannulus-part placement component, by pulling annulus part 52 to aproperly deployed position in mitral valve annulus 34, FIG. 5D.

At 814, tube 108 also functions as a ventricle-part release component,carrying ventricle part 54 (e.g., crimped on proximal balloon 112) outof delivery housing 76 into the volume of left ventricle 28, FIG. 5B.

At 816, a proximal end of filament 72 is pulled proximally (e.g.,through the proximal end of delivery housing 76) while delivery housing76 is held in place. Optionally, filament 72 functions as a joiningcomponent, bringing annulus part 52 and ventricle part 54 together, bypulling ventricle part 54 over mitral valve leaflets 38, 40 and/or theproximal portion of annulus part 52, FIG. 5F.

At 818, optionally balloon inflation tube 108 is withdrawn from deliveryhousing 76 in a proximal direction. Optionally, a crimping tool is usedto crimp connectors (e.g., three) around the distal ends of filament 72(e.g., three) near the inner face of tabs 58. The crimping mutuallyfixing annulus part 52 and ventricle part 54.

At 820, optionally delivery housing 76 is withdrawn from heart 10.

In some of the embodiment of the method described above, a crimping tool102 and/or a video camera 103 were advanced through delivery lumen 78 ofdeployment device 74 to assist in deploying a prosthetic mitral valve.Alternatively, one or more of crimping tools, video cameras, and/orother devices for assisting in deploying a prosthetic mitral vale asdescribed herein are brought to a desired location through a differentaccess routes, for example, through the vasculature and into the heartthrough the aorta, for example, using a suitable catheter.

In some of the embodiments described above, a prosthetic mitral valveincludes a valve mechanism that is not subject to prolapse of leafletsinto the left atrium, whether due to the particular construction of thevalve mechanism or due to the presence of a prolapse-preventingcomponent. In some, non-depicted, embodiments, a prosthetic mitral valveas described herein includes a prolapse-preventing component that issubstantially an artificial chorda, for example as described in WO2009/134701. In some such embodiments, the artificial chordae aredeployed substantially as described for a tether (in some embodimentsinstead of a tether, in some embodiments together with a tether), withthe required differences as are clear to a person skilled in the art.Specifically, in such embodiments, the device further comprises aleaflet-valve mechanism functionally associated with the annulus partand at least one artificial chorda having a distal chorda end and aproximal chorda end, the distal chorda end secured to a portion(typically an edge) of at least one leaflet of the leaflet-valvemechanism and the proximal chorda end configured for securing inproximity of the apex of a heart in which deployed, for example, securedto an anchor engaging heart muscle tissue, or passing through the heartmuscle and being anchored in place with a pad that presses against anouter wall of the heart. The chorda is configured (including the lengththereof) so that motion of the leaflet edge towards the left ventricleis substantially uninhibited, but that prolapse of the leaflet edge intothe left atrium is substantially prevented.

In some of the embodiments described above, the ventricle part of aprosthetic mitral valve is configured to at least partially encirclenative mitral valve leaflets and is deployed at least partiallyencircling the native mitral valve leaflets. In some embodiments, theventricle part of a prosthetic mitral valve is not necessarilyconfigured to encircle native mitral valve leaflets and/or is notdeployed at least partially encircling the native mitral valve leaflets.In some such embodiments, when deployed the ventricle part of such anembodiment of a prosthetic mitral valve encircles the proximal portionof the annulus part and. of necessary, is fixed thereto. By virtue ofhaving a larger diameter than the diameter of the mitral valve annulus(especially during atrial systole), such a ventricle part cannot passthrough the mitral valve annulus and thereby prevents the prostheticmitral valve from moving into the left atrium, especially because themitral valve annulus constricts during ventricular systole when there isthe greatest possibility of such movement.

In the embodiments described above, the teachings herein are implementedto provide a prosthetic heart valve that is a prosthetic mitral valve,having features rendering the prosthetic heart valve exceptionallyuseful for overcoming challenges in the field of prosthetic mitral valvedeployment. In some, non-depicted, embodiments, the teachings herein areimplemented, with the required changes, to provided a prosthetic heartvalve that is a prosthetic aortic valve.

In some embodiments, at least one of the annulus part and the ventriclepart of a prosthetic mitral valve as described herein includes bendingmating features, configured to be bent (in this context bent being anadjective, not a verb) when the annulus part and the ventricle part aremated (in this context, mated being an adjective not verb). For example,in some embodiments similar to valves 50 and 104, the three distal endsof filament 72 passes through gaps such as slots in the structure ofventricle part 52 and are secured to bendable tabs (integrally formed orconnected) that can pass into the gaps in annulus part. In such anembodiment, the gaps and the bendable tabs are mating features. When theproximal end of filament 72 is pulled to join annulus part 52 andventricle part 54, the bendable tabs are pulled to pass into the gaps,so that the two parts are mated. With further pulling of the proximalend of filament 72, the bendable tabs are bent downwards, lockingannulus part 52 and ventricle part 54 together. Subsequently, filament72 can be cut as described with reference to prosthetic mitral valve 50or anchored to function as a tether as described with reference toprosthetic mitral valve 104.

Any suitable combination of materials and methods of manufacture may beused in implementing the teachings herein. For example, a person havingordinary skill in the art of prosthetic cardiac valves is able to selectsuitable materials and methods of manufacture, for example, withreference to commercially-available prosthetic cardiac valves.

The dimensions of the various parts and components of the prostheticmitral valves and the deployment devices as described herein are anysuitable dimensions, and can be determined by a person having ordinaryskill in the art, for example, with reference to commercially-availabletransapical delivery devices and accompanying prosthetic cardiac valves,especially prosthetic mitral valves, for example the Perimount™ Magnaprosthetic mitral heart valve by Edwards Lifesciences LLC (Irvine,Calif., USA).

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the scope of the appendedclaims.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination or as suitable in any other describedembodiment of the invention. Certain features described in the contextof various embodiments are not to be considered essential features ofthose embodiments, unless the embodiment is inoperative without thoseelements.

Citation or identification of any reference in this application shallnot be construed as an admission that such reference is available asprior art to the invention.

Section headings are used herein to ease understanding of thespecification and should not be construed as necessarily limiting.

What is claimed is:
 1. A method of deploying an expandable prostheticmitral valve device in a subject, said method comprising: deploying afirst component of said prosthetic mitral valve device in a left atrium,the first component including an annulus part; deploying a secondcomponent of said prosthetic mitral valve in a left ventricle, thesecond component including a ventricle part; and approximating saidfirst and said second components so that one or more leaflets of anative mitral valve are trapped between said first and said secondcomponents, the method being performed using apparatus comprising: theprosthetic mitral valve device for fitted insertion to a native mitralvalve annulus of a heart of the subject, the prosthetic mitral valvecomprising the annulus part and the ventricle part; and a deploymentdevice for deployment of the prosthetic mitral valve device, thedeployment device comprising: a delivery housing configured to house theannulus part and the ventricle part of the prosthetic mitral valvedevice in radially-compact configurations, wherein: the annulus part andthe ventricle part are each configured to be radially expandablesubsequent to release from the delivery housing, and the expandedventricle part and the expanded annulus part are shaped to mate in adeployed mating configuration, such that there is a gap between theventricle part and the annulus part, the gap being configured toaccommodate one or more leaflets of the native mitral valve; and anapproximator that is configured, while attached to both the annulus partand the ventricle part: to force each of the annulus part and theventricle part toward the other from initially separated positions intothe mating configuration, such that the one or more leaflets of thenative mitral valve are held within the gap between the ventricle partand the annulus part; and to secure the annulus part and the ventriclepart in the mating configuration.
 2. A method according to claim 1,wherein said approximating comprises approximating by pulling a wireconnecting said first and second elements.
 3. A method according toclaim 1, further comprising joining said first and second elements tomaintain an approximated position.
 4. A method according to claim 1,wherein said approximating comprises tightly trapping said native mitralvalve leaflets.
 5. A method according to claim 1, further comprisingpiercing said leaflets by at least one of said first or said secondcomponents.
 6. A method according to claim 1, further comprisingpiercing tissues surrounding said leaflets by at least one of said firstor said second components.
 7. A valve deployment system comprising: aprosthetic mitral valve device for fitted insertion to a native mitralvalve annulus of a heart, the prosthetic mitral valve comprising anannulus part and a ventricle part; and a deployment device fordeployment of the prosthetic mitral valve device, the deployment devicecomprising: a delivery housing configured to house the annulus part andthe ventricle part of the prosthetic mitral valve device inradially-compact configurations, wherein: the annulus part and theventricle part are each configured to be radially expandable subsequentto release from the delivery housing, and the expanded ventricle partand the expanded annulus part are shaped to mate in a deployed matingconfiguration, such that there is a gap between the ventricle part andthe annulus part, the gap being configured to accommodate one or moreleaflets of the native mitral valve; and an approximator that isconfigured, while attached to both the annulus part and the ventriclepart: to force each of the annulus part and the ventricle part towardthe other from initially separated positions into the matingconfiguration, such that the one or more leaflets of the native mitralvalve are held within the gap between the ventricle part and the annuluspart; and to secure the annulus part and the ventricle part in themating configuration.
 8. The valve deployment system of claim 7, whereinsaid annulus part includes a valve mechanism suitable for functioning asa prosthetic mitral valve.
 9. The valve deployment system of claim 7,further comprising an annulus-part expansion assembly, configured toapply a radially outwards force to an inner surface of said annulus partsubsequent to release from said delivery housing to radially expand saidannulus part from the radially-compact configuration.
 10. The valvedeployment system of claim 9, wherein said annulus part and saidannulus-part expansion assembly are together configured so that saidexpanded annulus part conforms to an atrial contour near a native mitralvalve of said mitral valve annulus.
 11. The valve deployment system ofclaim 7, wherein said annulus part is self-expanding from theradially-compact configuration subsequent to release from said deliveryhousing.
 12. The valve deployment system of claim 11, wherein saidexpanded annulus part is configured to dynamically conform to an atrialcontour near a native mitral valve of said mitral valve annulus.
 13. Thevalve deployment system of claim 7, further comprising a ventricle-partexpansion assembly, configured to apply a radially outwards force to aninner surface of said ventricle part subsequent to release from saiddelivery housing to radially expand said ventricle part from theradially-compact configuration.
 14. The valve deployment system of claim7, wherein said ventricle part is self-expanding from theradially-compact configuration subsequent to release from said deliveryhousing.
 15. The valve deployment system of claim 7, wherein theapproximator comprises at least one elongated tether having a distal endfunctionally associated with said annulus part and a proximal endconfigured for securing in proximity of an apex of said heart, so that aforce applied to said proximal end of said tether is at least partiallytransferred by said annulus part to an atrial surface near said nativemitral valve annulus.
 16. The valve deployment system of claim 7,wherein the approximator comprises at least one elongated tether havinga distal end functionally associated with said ventricle part and aproximal end configured for securing in proximity of an apex of saidheart, wherein a portion of said tether passes through said annulus partso that force applied to said proximal end of said tether pulls saidventricle part towards said annulus part, and is at least partiallytransferred by said annulus part to an atrial surface near said nativemitral valve annulus.
 17. The valve deployment system of claim 7,further comprising an annulus-part placement component functionallyassociated with said annulus part, configured to assist in properlypositioning said annulus part in said native mitral valve annulus. 18.The valve deployment system of claim 17, said annulus-part placementcomponent being configured to also function as a deployable tether. 19.The valve deployment system of claim 7, wherein at least one of saidannulus part and said ventricle part include bending mating features,configured to be bent when said annulus part and said ventricle part aremated, and wherein said approximator is configured to bend said bendingmating features.
 20. The valve deployment system of claim 7, whereinsaid approximator is further configured to function as a ventricle-partrelease component.
 21. The valve deployment system of claim 7, whereinsaid approximator is further configured to function as an annulus-partplacement component.
 22. The valve deployment system of claim 7, whereinsaid approximator is further configured to function as a deployabletether.
 23. The valve deployment system of claim 7, wherein: theexpanded ventricle part and the expanded annulus part are shaped to matein the deployed mating configuration, such that the ventricle partradially encircles the annulus part around a circumference of theannulus part surrounding and defining an annulus; and said radialencircling is at a position at which the annulus part and the ventriclepart are configured to hold the one or more leaflets of said nativemitral valve annulus within the gap between said ventricle part and saidannulus part when the valve is deployed with the annulus and ventricleparts in the mating configuration.
 24. The valve deployment system ofclaim 7, wherein the expanded annulus part and the expanded ventriclepart each narrow from wider to narrower between their respective distaland proximal portions, the proximal portions being configured to bepositioned further in a direction toward the ventricle in the deployedconfigurations of the annulus and ventricle parts, and the ventriclepart is configured to radially encircle the proximal portion of saidannulus part in the deployed configurations of the annulus and ventricleparts.
 25. The valve deployment system of claim 7, wherein theapproximator operates to pull the ventricle part toward the annulus partto a position on a ventricular side of the prosthetic mitral valve, suchthat the ventricle part, at said position, is configured to at leastpartially encircle both a proximal portion of the annulus part and theone or more leaflets of the native mitral valve.
 26. The valvedeployment system of claim 7, wherein the deployment device is operableto deploy the prosthetic mitral valve device using at least one of atransapical approach, or a vascular approach.
 27. The valve deploymentsystem of claim 7, wherein the deployment device is operable to deploythe prosthetic mitral valve via a transseptal approach.
 28. The valvedeployment system of claim 7, wherein the approximator comprises aplurality of filaments each of which extends from the deployment deviceat one filament end to another filament end that is secured to theventricle part, each of the filaments contacting a region of slidableassociation with the annulus part between the filament ends.
 29. Thevalve deployment system of claim 28, wherein said approximator isconfigured to be releasably secured to said ventricle part.
 30. Thevalve deployment system of claim 28, wherein said approximator isconfigured to be fixedly secured to said ventricle part.